Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated Control Arm, in Prevention of Post Abdominal Surgery Incisional Infection.

Prevention of post abdominal surgery incisional infection.

Infection rate as measured by the proportion of subjects with at least one abdominal target incisional infection event, occurring within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee, in the study population with longer incision (>20cm). [abdominal incisional infection is defined as Deep Incisional Surgical Site Infection (DSSI) and/or Superficial Incisional Surgical Site Infection (SSSI)].

Infection rate as measured by the proportion of subjects with at least one abdominal target incisional infection event, occurring within 30 days post abdominal (index) surgery and determined by a blinded and independent adjudication committee, in the population of subjects with target incision length >20cm., Infection rate as measured by the proportion of subjects with at least one abdominal target incisional infection event, occurring within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee, in the overall study population (incision ≥7cm). All-cause mortality and re-interventions through the abdominal incision (target) within 30 days post index surgery will be analysed as treatment failure., Number (percent) of subjects with at least 1 score of ASEPSIS > 20, within 30 days post abdominal (index) surgery (population of subjects with target incision length >20cm)., Additional endpoints (population of subjects with target incision length >20cm): Incidence of SSSI during 30 days post index surgery., Additional endpoints (population of subjects with target incision length >20cm): Incidence of DSSI during 30 days post index surgery., Additional endpoints (population of subjects with target incision length >20cm): All-cause mortality rate within 30 days post randomization., Additional endpoints (population of subjects with target incision length >20cm): All-cause mortality rate within 60 days post randomization., Additional endpoints (population of subjects with target incision length >20cm): Time to adjudicated SSI during 30 days post index surgery., Additional endpoints (population of subjects with target incision length >20cm): Number (percent) of subjects re-admitted during 30 days post index surgery (for any reason) that have experienced adjudicated SSI during this re-admission., Additional endpoints (population of subjects with target incision length >20cm): Number (percent) of subjects who experienced at least 1 surgical re-intervention due to adjudicated SSIs during 30 days post index surgery., SSI related Additional Endpoints: Number (percent) of subjects with adjudicated SSI where at least one Doxycycline-resistant bacteria have grown in bacteriology tests., SSI related Additional Endpoints: Number (percent) of Doxycycline-resistant bacteria out of all bacteria that were cultured during bacteriology test from subjects with adjudicated SSI., SSI related Additional Endpoints: Number (percent) of subjects who experienced adjudicated SSI during 30 days post index surgery that were treated by IV antibiotic., SSI related Additional Endpoints: Number of IV antibiotic treatment days, administered to subjects who experience adjudicated SSI during 30 days post index surgery., SSI related Additional Endpoints: Average of subjects’ cumulative ASEPSIS assessment score (AUC) for subjects with adjudicated SSI during 30 days., SSI related Additional Endpoints: Number (percent) of subjects with at least 1 score of ASEPSIS > 20 in subject with adjudicated SSI within 30 days post abdominal (index) surgery.

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